Low-profile heart valve and delivery system

ABSTRACT

Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/326,062, filed Jul. 8, 2014, now U.S. Pat. No. 9,901,446, which is adivisional of U.S. patent application Ser. No. 13/040,896, filed Mar. 4,2011, now U.S. Pat. No. 8,795,354, which claims the benefit of U.S.Patent Application No. 61/311,165, filed Mar. 5, 2010, the disclosuresof all of which are incorporated by reference herein.

FIELD

The present invention relates to implantable devices. More particularly,the present invention relates to devices and methods for implantation ofa prosthetic heart valve.

BACKGROUND

A transcatheter heart valve (THV) is a prosthetic, or replacement, heartvalve which is configured to be implanted by a catheterizationtechnique. One type of THV has been developed by Edwards Lifesciences ofIrvine, Calif. and is described in U.S. Pat. No. 6,730,118, which ishereby incorporated by reference in its entirety. The THV described inthe '118 patent is primarily configured for replacing the function of astenotic aortic valve in a human heart. An important feature of the THVis the ability to be implanted within the stenotic region of the nativeaortic valve. After implantation, the THV holds open the leaflets of thenative aortic valve and utilizes the native valve annulus as anattachment means for the THV.

Such transcatheter techniques traditionally involve the implantation ofa prosthetic valve that can be compressed or folded to a reduceddiameter. By compressing or folding the prosthetic valve to a reduceddiameter, the prosthetic valve can be delivered through a less invasivepenetration to a desired target location within the human anatomy.Thereafter, the compressed valve is traditionally released, expanded,separated from the delivery system, and secured to the desired targetlocation.

An important design parameter of the THV is the diameter of its foldedor crimped profile. The diameter of the crimped profile is importantbecause it directly influences the physician's ability to advance theTHV through the femoral artery or vein. More particularly, a smallerprofile allows for treatment of a wider population of patients, withenhanced safety.

U.S. Pat. No. 7,381,219 (the '219 patent) discloses a replacement heartvalve having a replacement valve collapsed within the lumen of ananchor. Col. 7, lines 35-36. “Retraction of wires 50 relative to tubes60 foreshortens anchor 30, which increases the anchor's width whiledecreasing its length.” Col. 7, lines 36-38. The '219 patent alsodiscloses a two-piece apparatus comprising an expandable anchor pieceand an expandable replacement valve piece. The anchor piece includes agroove section that is “adapted to engage an expandable frame portion”of the valve piece, in order to couple the anchor piece to the valvepiece. Col. 17, lines 38-41. Such coupling can be complicated to performand can make implantation difficult.

European Patent EP 1 872 743 discloses a cardiovascular valve assemblycomprising a replaceable valve member and an expandable base memberdesigned to account for patient growth. “After installation of basemember 100, tubular body 110 may be dilated to a small diameter during afirst procedure. A valve member 20 having a small diameter frame 30 canbe docked with base member 100 by insertion of fingers 50 into opening154.” Col. 7, line 57 to col. 8, line 4. Again, this method of insertingfingers into openings in the disclosed design can be complicated toperform.

International Application No. PCT/US2008/001590 discloses a valve having“a valve leaflet 104 that] can be coupled adjacent to the proximal end112 of the valve frame 102 at junction points 120.” Page 4. A “leaflettransition member 110 [is] coupled to at least a portion of the valveleaflet 104 and/or the leaflet frame 111. Page 4. “Elongate pushmembers” on a delivery catheter “can be used to push the leaflettransition member 310 inside the lumen 308 of the valve 300.” Page 10.

These replacement heart valves can be complicated to manufacture and/orimplant within a patient's body. A need thus remains for an improvedreplacement heart valve that can address these and other disadvantagesassociated with conventional replacement heart valves.

SUMMARY

Traditionally, replacement valves, such as replacement heart valves(e.g., the THV) are crimped directly onto a balloon of a ballooncatheter and the crimped replacement valve and balloon are navigatedthrough the patient's vasculature to the implantation site. Because ofthe thickness of the balloon material, the valve cannot be crimped toits smallest possible profile. In certain embodiments disclosed below,at least a portion of the disclosed replacement valves can be crimped onto a delivery catheter at a location separate from the balloon and/orthe valve portion and stent or anchor portion of the replacement valvecan be axially separated from one another when crimped on the deliverycatheter. This allows some embodiments of the disclosed replacementvalves to be crimped to a smaller diameter than conventional replacementheart valves. After the THV is advanced through narrow portions in apatient's vasculature (for example, the iliac artery), some embodimentsof the disclosed replacement valves can be transitioned from thedelivery configuration to an operating configuration. Suchtransitioning, or transformation, can be completed before or afterpositioning the replacement valve within the native valve annulus.

Generally, disclosed replacement valves are adapted to be radiallycollapsed or compressed (e.g., crimped) to facilitate navigation throughthe narrow passages of a patient's vasculature to the treatment sitewithin the patient's body. After the replacement valve reaches thetreatment site (e.g., the aortic valve annulus) and/or has traveledthrough the narrowest parts of the patient's vasculature, thereplacement valve can be radially expanded within the native valveannulus. At some point during delivery of disclosed replacement valves,the valve can be expanded and/or transitioned from a deliveryconfiguration, which can minimize the crimped profile, to an operatingconfiguration. In some embodiments, the replacement valve is expandedsuch that at least a portion of the replacement valve has a diametersufficient to engage the native valve annulus. In some embodiments, thereplacement valve can both be expanded and transitioned to an operatingconfiguration, as will be explained in further detail below.

Certain embodiments of a prosthetic valve (e.g., a replacement heartvalve) comprise a stent portion (e.g., a generally tubular stentportion) defining a lumen through said stent portion, a valve portioncomprising one or more leaflets, and a flexible sleeve configured tocouple the valve portion to the stent portion. The prosthetic valve canbe transformable from a delivery configuration, in which at least aportion of the one or more leaflets is positioned outside the lumen ofthe stent portion, to an operating configuration, in which at least aportion of the one or more leaflets is positioned within the lumen ofthe stent portion.

In some embodiments of a prosthetic valve, the stent portion is coupledto the valve portion by a flexible sleeve. A lower portion of theflexible sleeve can be positioned within the lumen of the stent portion,and the flexible sleeve can extend from the lower portion to an upperportion, wherein the upper portion of the flexible sleeve is positionedadjacent an exterior surface of the valve portion. In some embodiments,the valve portion can be configured to be pushed or pulled into thelumen of the stent portion, resulting in the flexible sleeve beingpositioned between an outer surface of the valve portion and an innersurface of the stent portion once the prosthetic valve is transformed ortransitioned to the operating configuration.

In particular embodiments, the one or more leaflets can each comprise afree end and a secured end. Each of the secured ends of the leaflets canbe coupled to the flexible sleeve, and each of the free ends of theleaflets can be freely moveable apart from the flexible sleeve. In someembodiments, while the replacement valve is in the deliveryconfiguration, the one or more leaflets can be arranged such that eachof the secured ends is positioned above each of the free ends, and whilethe replacement valve is in the operating configuration, the one or moreleaflets can be arranged such that each of the secured ends ispositioned below each of the free ends. Thus, the leaflets can beinverted during the process of transitioning from the deliveryconfiguration to the operating configuration.

In some embodiments of a replacement valve comprising a flexible sleeve,the flexible sleeve can be flipped inside out (e.g., inverted) duringtransitioning between the delivery configuration and the operatingconfiguration. For example, the flexible sleeve can comprise an innersurface facing the lumen of the stent portion and an outer surface towhich the one or more leaflets are coupled while in the deliveryconfiguration. The stent portion can comprise a lumen surface definingthe lumen of the stent portion and an external surface, and the innersurface of the flexible sleeve can be coupled to the external surface ofthe stent portion. In the operating configuration, at least a portion ofthe outer surface of the flexible sleeve can be positioned within andfacing the lumen of the stent portion. Thus, the flexible sleeve can beflipped inside out (or outside in).

Certain embodiments can include a temporary valve. The valve portion canbe coupled to a first end of the stent portion, and the temporary valvecan be coupled to a second end of the stent portion, opposite the firstend of the stent portion. Such temporary valves can function as aninterim replacement heart valve while the main replacement valve isbeing positioned and/or transitioned to the operating configuration.Once the main replacement valve has been fully implanted and deployed,the temporary valve can be removed, such as by being removed along withthe delivery system, in some embodiments. Alternatively, the temporaryvalve can be resorbable or can simply remain in the native valve,coupled to the main replacement valve. For example, in some embodiments,the flexible sleeve can include at least one slit through which bloodcan flow at least when the valve is in the delivery configuration. Theslits can thus function as a temporary valve in some embodiments. Inthese embodiments, the temporary valve is not removed after it is nolonger necessary (e.g., after the valve portion of the replacement valveis fully deployed and operating).

The valve portion can be coupled to the stent portion of the replacementvalve in a variety of ways. For example, in some embodiments, the stentportion can be coupled to the valve portion by a longitudinal slidingrail. In some embodiments, the stent portion can be coupled to the valveportion by one or more hinges configured to allow the one or moreleaflets to be inverted from a first position outside the lumen of thestent portion to a second position within the lumen of the stentportion. In other embodiments, the valve portion can be coupled to thestent portion of the replacement valve by, for example, connectingmembers, extensions of the stent portion, and/or a flexible sleeve orskirt.

One embodiment of a prosthetic valve can comprise a radially collapsibleand expandable frame and a leaflet structure. The leaflet structure cancomprise a plurality of leaflets, a plurality of reinforcement elements,and a plurality of leaflet-supporting members. The frame can be coupledto the leaflet structure, such that the leaflets are positioned at leastsubstantially outside of the frame, wherein a portion of each of theleaflets is positioned in a respective gap formed between a respectivereinforcement element and a respective leaflet-supporting member.

In some embodiments, the frame can be coupled to the leaflet structureby a plurality of connecting members. For example, the frame and theconnecting members can each comprise a plurality of open cells. Theframe can comprise open cells substantially around its entirecircumference, while the connecting members can comprise a few opencells extending from the frame to the leaflet structure. In someembodiments, each of the leaflet-supporting members of the leafletstructure can be positioned to be a boundary for the plurality of opencells. Thus, in some embodiments, no open cells extend into the windowsdefined by the reinforcement arcs, and thus there are no open cellsexternal to the leaflets in some embodiments (e.g., none of the opencells are positioned between the leaflets and the native valve annulus).

Some embodiments of a prosthetic valve can include a flexible sleevepositioned adjacent at least a portion of the frame. In someembodiments, the flexible sleeve can be configured to couple the leafletstructure to the frame.

In certain embodiments, at least a portion of each of theleaflet-supporting members can be separated from the frame along theaxial direction. For example, certain portions of the leaflet structurecan be coupled to certain portions of the frame, such as by connectingmembers, while other portions of the leaflet structure can be free fromthe frame (e.g., in areas without connecting members, there can exist agap along the axial direction between the leaflet structure and theframe). In some embodiments, the prosthetic valve can be configured tobe transformable from a delivery configuration in which each of theleaflet-supporting members is separated from the frame along the axialdirection, to an operating configuration in which a least a portion ofeach of the leaflet-supporting members is positioned within a lumen ofthe frame

Some embodiments of a prosthetic valve can be configured such that theleaflet structure is positioned supraannularly to a native valveannulus. For example, in some embodiments, the frame can be positionedwithin the native valve annulus, while the leaflet structure ispositioned supraannularly (e.g., above the native valve annulus).

Particular embodiments can be configured such that the reinforcementelements are arranged to form a duckbill shape, with each pair ofadjacent reinforcement elements joined to one another at a commissurepoint.

In some embodiments, the frame can be coupled to the leaflet structureby at least one sliding rail.

In some embodiments, the frame can be configured to expand to anexpanded diameter sufficient to engage a native valve annulus, therebyanchoring the prosthetic valve, and the leaflet structure can beconfigured to expand to a second diameter less than the expandeddiameter, so as to not contact the native valve. In some embodiments,the frame does not overlap the leaflet structure.

Methods of implanting replacement heart valves are also disclosed. Insome such methods, the replacement heart valve can comprise a stentportion, a valve portion, and a flexible sleeve coupled to the stentportion. The stent portion can comprise an outer surface and an innersurface defining a lumen, and the valve portion can comprise a pluralityof leaflets. While the replacement valve is in the deliveryconfiguration, at least a portion of the leaflets can be positionedoutside of the lumen defined by the stent portion. In some methods, thereplacement heart valve can be mounted onto a delivery system in adelivery configuration, advanced to an implant position adjacent a heartvalve annulus, transitioned from the delivery configuration to anoperating configuration, and radially expanded so as to anchor it withinthe heart valve annulus. For example, the replacement heart valve can beexpanded such that the stent portion engages the heart valve annulus,thereby anchoring the replacement heart valve in position within theheart valve annulus. In some methods, while the replacement valve is inthe operating configuration at least a portion of the leaflets can bepositioned within the lumen defined by the stent portion.

In some methods, the delivery system is removed from the replacementheart valve. Transitioning the replacement valve from the deliveryconfiguration to the operating configuration can occur prior to removingthe delivery system from the replacement heart valve.

In some methods, a lower end of the flexible sleeve can be coupled tothe stent portion, and transitioning the replacement valve from thedelivery configuration to the operating configuration can compriseinverting the flexible sleeve such that an upper end of the flexiblesleeve opposite the lower end of the flexible sleeve is moved to aposition within the lumen of the stent portion. In some embodiments, theflexible sleeve can be folded onto itself as the valve portion ispositioned within the lumen of the stent portion. The flexible sleevecan comprise a plurality of slits arranged to function as a temporaryvalve during implanting of the replacement valve.

In certain methods, a lower end of the flexible sleeve can be coupled tothe inner surface of the stent portion, and transitioning thereplacement valve from the delivery configuration to the operatingconfiguration can comprise folding the flexible sleeve onto itself asthe valve portion is positioned within the lumen of the stent portion.

In some methods, transitioning the replacement valve from the deliveryconfiguration to the operating configuration can comprise partiallyexpanding the stent portion into a tapered configuration and positioningthe valve portion at least partially within the lumen of the stentportion. Radially expanding the replacement heart valve can compriseexpanding fully the valve portion and the stent portion together.

Various steps of the disclosed methods can generally be performed indifferent orders. For example, advancing the replacement heart valve toan implant position can occur after positioning the valve portion atleast partially within the lumen of the stent portion in someembodiments. Alternatively, advancing the replacement heart valve to animplant position can occur before positioning the valve portion at leastpartially within the lumen of the stent portion.

In embodiments of methods that include transitioning the replacementvalve from a delivery configuration to an operating configuration,disclosed methods can employ any suitable technique for transitioningthe replacement valve. For example, transitioning the replacement valvefrom the delivery configuration to the operating configuration cancomprise sliding the valve portion along a sliding rail into positionwithin the lumen of the stent portion. In some embodiments,transitioning the replacement valve from the delivery configuration tothe operating configuration can comprise inverting the plurality ofleaflets from a first position outside of the lumen of the stent portionto a second position within the lumen of the stent portion.

The present disclosure also concerns embodiments of a prosthetic heartvalve system. Such embodiments can include a delivery apparatuscomprising an expansion device and a delivery catheter on which theexpansion device is mounted and a radially-expandable replacement valvemounted in a radially compressed state on the delivery catheter. Thereplacement valve can comprise a valve portion and a stent portionseparated from one another along an axial direction and coupled by atleast one pair of sliding rails. The expansion device can be configuredto expand the replacement valve and to position at least part of thevalve portion within a lumen of the stent portion by moving valveportion along the at least one pair of sliding rails.

The foregoing and other objects, features, and advantages of theinvention will become more apparent from the following detaileddescription, which proceeds with reference to the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of a replacement heartvalve according to the present disclosure.

FIG. 2 is a perspective view of the replacement valve of FIG. 1, shownimplanted in a patient's aortic valve.

FIG. 3 is an elevation view of the frames of the replacement valvesshown in FIGS. 1-2, cut open and laid flat.

FIG. 4 is a perspective view of another embodiment of a replacementheart valve, in a delivery configuration.

FIG. 5 is a perspective view of the replacement heart valve shown inFIG. 4, in an operating configuration.

FIG. 6 shows a perspective view of the frame of another embodiment of areplacement heart valve.

FIG. 7 is a perspective view of one embodiment of a replacement heartvalve.

FIG. 8A is a section view of the replacement heart valve of FIG. 7,shown in a delivery configuration.

FIG. 8B is a section view of the replacement heart valve of FIG. 7,shown in an operating configuration.

FIG. 8C is a perspective view of the valve portion of one embodiment ofa replacement heart valve.

FIG. 9 is a perspective view of one embodiment of a replacement heartvalve according to the present disclosure, in a delivery configuration.

FIG. 10 is a perspective view of the replacement heart valve of FIG. 9,after being transitioned to an operating configuration.

FIG. 11 shows an elevation view of a replacement heart valve crimpedonto a delivery catheter.

FIG. 12 is a perspective view of a replacement valve being partiallyexpanded while on a delivery catheter.

FIG. 13 is a perspective view showing deflation of the balloon used toexpand the stent portion of a replacement heart valve according to onedisclosed method.

FIG. 14 is a perspective view of the valve portion of a replacementheart valve being pushed into the stent portion of the replacementvalve.

FIG. 15 is an elevation view of a replacement heart valve beingpositioned within a patient's native valve annulus.

FIG. 16 shows an elevation view of the replacement heart valve of FIG.15 being fully expanded within the native valve annulus by an inflatedballoon.

FIG. 17 shows an elevation view of a replacement heart valve in place ina native valve after deployment is complete.

FIG. 18 shows an elevation view of a replacement heart valve crimpedonto a delivery catheter being positioned within a patient's nativevalve, according to one disclosed method.

FIG. 19 is a perspective view of the stent portion of a replacementvalve being expanded, while the valve portion of the replacement valveremains crimped onto the delivery catheter.

FIG. 20 is an elevation view of the replacement valve shown in FIGS.18-19, with the valve portion being pushed into the stent portion of thereplacement heart valve.

FIG. 21 is an elevation view of the replacement heart valve being fullyexpanded to an operating configuration within a patient's native valveannulus.

FIG. 22 is a perspective view of one embodiment of a valve portion of areplacement heart valve.

FIG. 23 is a perspective view of one embodiment of a stent portion of areplacement heart valve.

FIG. 24 is a perspective view of one embodiment of a replacement heartvalve having moveable leaflets, shown in a delivery configuration.

FIG. 25 is a perspective view of the replacement heart valve of FIG. 24,with the leaflets shown in an operating configuration.

FIG. 26 is a perspective view of a two-part replacement heart valve.

FIG. 27 is an elevation view of a two-part replacement heart valvecrimped onto a delivery system.

FIG. 28 is a perspective view of one embodiment of a replacement heartvalve.

DETAILED DESCRIPTION

As used in this application and in the claims, the singular forms “a,”“an,” and “the” include the plural forms unless the context clearlydictates otherwise. Additionally, the term “includes” means “comprises.”Further, the terms “coupled” generally means electrically,electromagnetically, and/or physically (e.g., mechanically orchemically) coupled or linked and does not exclude the presence ofintermediate elements between the coupled items.

As used herein, the “expanded” or “deployed” state of a valve assemblyor frame refers to the state of the valve assembly/frame when radiallyexpanded to its functional size. The “crimped”, “compressed” or “folded”state of a valve assembly or frame refers to the state of the valveassembly/frame when radially compressed or collapsed to a diametersuitable for delivering the valve assembly through a patient'svasculature on a catheter or equivalent mechanism. “Partially crimped”or “partially compressed” or “partially expanded” means that at least aportion of a valve assembly/frame has a diameter that is less than thediameter of the valve assembly/frame in the expanded state and greaterthan the diameter of the valve assembly/frame in the compressed state.

The terms “delivery configuration” and “operating configuration” referto the arrangement of the components of the replacement valve relativeto one another, and each term includes both crimped and non-crimped(e.g., expanded) states. The term “fully assembled” refers toreplacement valves in which all required components are coupledtogether, and thus a replacement valve can be considered fully assembledin both delivery and operating configurations, even when in a crimpedposition on a delivery catheter.

Terms such as “above,” “upper,” “below,” and “lower” are meant only toshow the position of some features relative to others as shown in thedrawings, and do not necessarily correlate to actual positions ordirections of those features when the replacement valve is beingdelivered and/or is in its implanted configuration or position.

Descriptions and disclosures provided in association with one particularembodiment are not limited to that embodiment, and may be applied to anyembodiment disclosed.

Moreover, for the sake of simplicity, the figures may not show thevarious ways (readily discernible, based on this disclosure, by one ofordinary skill in the art) in which the disclosed system, method, andapparatus can be used in combination with other systems, methods, andapparatuses.

Disclosed embodiments of a replacement heart valve can be designed fordelivery and implantation using minimally invasive techniques. Forexample, disclosed replacement heart valves can be crimped onto adelivery catheter, navigated through a patient's vasculature, andexpanded before or during implantation in a native valve site, such asthe native aortic valve. As such, the minimum crimped diameter (e.g.,the profile of the crimped replacement valve on the delivery system) canbe of utmost importance to the success and/or ease of performing of theprocedure.

The minimum crimped diameter is dictated at least in part by the amountof material that the valve contains in its radial direction. Prior artvalves sought to create a reduced crimped diameter by either separatingcomponents of the valve axially, which created a relatively longapparatus, or assembling the valve after crossing the narrowest portionof the vasculature (e.g., the arc of the femoral artery). Embodiments ofthe presently disclosed heart valves can be fully assembled prior toinsertion into a patient. For example, in some embodiments differentcomponents of a replacement heart valve need not be coupled togetherduring delivery, but rather, the components are just moved relative toone another while remaining coupled together. In some embodiments,portions of the replacement valve are not separable from one anotherwithout damage to (e.g., destruction of) the replacement valve.

FIGS. 1-3 illustrate one embodiment of a replacement heart valve 100that can be deployed, for example, at least partially in a patient'saorta 102. As shown in FIG. 2, replacement heart valve 100 can beimplanted such that the leaflets are positioned supraannularly withinthe aorta 102, while a portion of the replacement valve is positionedwithin the native valve annulus. FIG. 3 shows a flattened view of thereplacement valve 100 shown in FIGS. 1-2 (e.g., FIG. 3 shows replacementvalve 100 cut open and laid flat).

As with all disclosed embodiments, replacement valve 100 can beconfigured to be radially collapsible to a collapsed or crimped statefor introduction into the body on a delivery catheter and radiallyexpandable to an expanded state for implanting the valve at a desiredlocation in the body (e.g., the native aortic valve). At least part ofthe replacement valve 100 can be made of a plastically-expandablematerial (e.g., stainless steel, chromium alloys, and/or other suitablematerials) that permits crimping of the valve to a smaller profile fordelivery and expansion of the valve using an expansion device such asthe balloon of a balloon catheter. Alternatively or additionally, atleast part of the replacement valve 100 can be a so-calledself-expanding valve made of a self-expanding material such as Nitinol.For example, a self-expanding valve can include a self-expanding lowerportion (e.g., a self-expanding frame or stent) and/or a self-expandingleaflet support frame. A self-expanding valve can be crimped to asmaller profile and held in the crimped state with a restraining devicesuch as a sheath covering the valve. When the valve is positioned at ornear the target site, the restraining device can be removed to allow thevalve to self-expand to its expanded, functional size.

Replacement valve 100 comprises an inflow end 104 and an outflow end106. When in place within a patient's heart, blood flows into the valve100 at the inflow end 104 and out of the valve 100 at the outflow end106. Replacement valve 100 generally includes a lower portion 108adjacent the inflow end 104 and a leaflet portion 110 adjacent theoutflow end 106. Lower portion 108 can serve to keep the native valveopen and can be positioned within the native valve annulus 101. Lowerportion 108 can also help to fix or anchor the replacement valve 100 inplace with the patient's native valve (e.g., the lower portion 108 canbe positioned to be in contact with the aortic annulus and the nativevalve). Lower portion 108 can also serve as a basis for anchoring theleaflet portion 110, while the leaflet portion 110 can be positionedsupraannularly (e.g., above the native valve annulus 101) and need notcontact the aortic wall, but can contact the aortic wall in someembodiments. For example, in some embodiments, a gap can exist betweenthe leaflet potion 110 and the aortic wall (e.g., at least a part of theleaflet portion 110 does not contact the vessel wall in someembodiments). In some embodiments, the replacement valve 100 can bepositioned and sized relative to the patient's aorta such that a gapexists between the replacement valve 100 and the aortic wall and/oraortic sinuses. In this manner, blood can flow between the aortic walland the leaflet portion 110 (e.g., when the leaflets are closed, duringdiastole), thereby supplying blood to the coronary arteries. Thus, thelower portion 108 can anchor the replacement valve 100 in place againstthe native valve, while the leaflet portion 110 is not anchored to thenative valve or vessel in some embodiments. The valve can have a sealingmember 126 (FIG. 28) on the outside of the stent structure 112 to blockthe back flow of blood into the stent structure, through the aorticannulus, and into the left ventricle during diastole.

Lower portion 108 includes a stent structure, or anchor portion, 112(e.g., a wire mesh frame). The stent structure can comprise, forexample, one or more rows of open cells 115, arranged circumferentially.The leaflet portion 110 can include a leaflet support frame 113 thatcomprises reinforcement elements 114 a, 114 b, 114 c andleaflet-supporting members 116 a, 116 b, 116 c. The leaflet supportframe 113 can be a two-part scalloped frame in some embodiments. Inother embodiments, the leaflet support frame 113 can comprise a singleintegral body.

Reinforcement elements 114 a, 114 b, 114 c comprise respective upperarcs 122 connected to respective lower arcs 123 so as to definerespective windows, or openings 119. Respective reinforcement elements114 a, 114 b, 114 c can be arranged with respect to one another so as toform a duckbill shape as shown in FIG. 1, and can be connected to eachother by commissure posts 120. Such an arrangement can substantiallyprevent injury to the native tissue in some embodiments.

Lower arcs 123 of the reinforcement elements 114 a, 114 b, 114 c can bepositioned with respect to leaflet-supporting members 116 a, 116 b, 116b so as to define a gap 117 a, 117 b, 117 c therebetween. Leaflets 118a, 118 b, 118 c can be secured in the gap 117 a, 117 b, 117 c between arespective reinforcement element 114 a, 114 b, 114 c andleaflet-supporting member 116 a, 116 b, 116 c. For example, leaflet 118a can be secured in place in the gap 117 a defined by reinforcementelement 114 a and leaflet-supporting member 116 a.

A lower edge portion of each of the leaflets 118 a, 118 b, 118 c can besandwiched between the reinforcement elements and leaflet-supportingmembers, as shown in FIGS. 1 and 2 such that the leaflets 118 a, 118 b,118 c can operate (e.g., open and close) within windows 119 defined bythe reinforcement elements 114 a, 114 b, 114 c. Some suitable attachmentmethods are described in United States Patent Application PublicationNo. 2009/0157175 (the '175 Publication), which is hereby incorporatedherein by reference in its entirety. For example, in one specificembodiment described in the '175 Publication, the leaflets 118 can besecured (e.g., sutured) to a cloth which can substantially wrap aroundreinforcement elements 114 and leaflet-supporting members 116. Portionsof the cloth can be secured (e.g., sutured) together, therebyeffectively securing the reinforcement elements 114 to theleaflet-supporting members 116.

Some configurations can allow for the leaflets 118 a, 118 b, 118 c to besecured to the replacement valve 100 without being covered by a frame orstent structure (e.g., without any open cells 115 surrounding theleaflets 118 a, 118 b, 118 c, or without any open cells 115 positionedbetween the leaflets 118 a, 118 b, 118 c and the patient's valve). Forexample, the leaflet-supporting members 116 a, 116 b, 116 c can serve asa boundary for the open cells 115, such that none of the open cells 115cross or extend beyond the leaflet-supporting members 116 a, 116 b, 116c to overlap the leaflets 118 a, 118 b, 118 c, contrary to knowntranscatheter valves. In this manner, the support structure of the valve(usually metal) is substantially separated from the leaflets, therebyallowing the replacement valve 100 to be crimped to a relatively smalldiameter.

Commissure posts 120 are located between each of the leaflets 118 a, 118b, 118 c. Conventional replacement valves typically include commissureposts having sharp or abrupt edges that can be less than ideal forcontact with a patient's aorta wall or other native tissue.Reinforcement elements 114 a, 114 b, 114 c and leaflet-supportingmembers 116 a, 116 b, 116 c can substantially prevent contact betweensharp commissure points and the aorta wall such as by providing a smoothtransition between the reinforcement arcs and commissure posts 120.Further, the reinforcement arcs can increase the strength of commissureposts 120 and can help prevent the commissure posts 120 from collapsinginward when the leaflets 118 a, 118 b, 118 c are loaded (e.g., whensubjected to back pressure).

In some embodiments, lower portion 108 and leaflet portion 110 can forma single integral body. In some embodiments, lower portion 108 andleaflet portion 110 can be coupled to one another by connecting elements124. Connecting elements 124 can be configured as a partial extension ofthe stent structure 112 of the lower portion 108 and can be coupled tothe leaflet-supporting members 116 a, 116 b, 116 c. For example,connecting elements 124 can comprise a cluster of four open cells 115bridging between the lower portion 108 and the leaflet portion 110.Connecting elements 124 can extend to locations adjacent the commissureposts 120 positioned between adjacent pairs of leaflet-supportingmembers, but do not extend into the leaflet windows 119 (e.g., do notcross the leaflet-supporting members 116 a, 116 b, 116 c) in someembodiments. In other embodiments, lower portion 108 and leaflet portion110 are not coupled via connecting elements 124. Thus, lower portion 108and leaflet portion 110 can be constructed as two separate componentswhich are connectable together (e.g., couplable to one another).

While not shown for clarity in FIGS. 1-3, lower portion 108 can includea flexible sleeve (e.g., a skirt) and/or a sealing component covering atleast a portion of the stent structure 112. For example, a polyethyleneterephthalate (PET) fabric sleeve can cover at least a portion of thestent structure 112 such that the PET fabric sleeve can reduce orsubstantially eliminate leakage around the replacement valve 100. Oneembodiment of a suitable flexible skirt or sealing component 126 isshown in FIG. 28. As seen in FIG. 28, the skirt 126 can coversubstantially the entire outer surface of the stent structure 112,thereby reducing or substantially eliminating leakage around thereplacement valve 100 (e.g., leakage through the stent structure 112).The skirt 126 can substantially continuously contact and/or follow thecontours of one or more components of the leaflet portion 110. Forexample, as shown in FIG. 28, the skirt 126 can substantiallycontinuously contact and/or follow the contours of theleaflet-supporting members 116 a, 116 b, 116 c, thereby creatingsubstantially continuous sealing around the stent structure 112. In thismanner, the skirt 126 can substantially prevent blood from flowing intothe stent structure, through the aortic annulus, and back into the leftventricle during diastole.

FIG. 6 shows another embodiment of a replacement heart valve 600 thatcan be positioned supraannularly. Replacement valve 600 comprises aninflow end 604 and an outflow end 606. When in place within a patient'sheart, blood flows into the valve 600 at the inflow end 604 and out ofthe valve 600 at the outflow end 606. Replacement valve generallyincludes a lower portion 608 adjacent the inflow end 604 and a leafletportion 610 adjacent the outflow end 606. Lower portion 608 can serve tokeep the native valve open and can be positioned within the native valveannulus. Lower portion 608 can also help to fix or anchor thereplacement valve 600 in place with the patient's native valve (e.g.,lower portion 608 can be positioned within the native aortic valve).Lower portion 608 can also serve as a basis for anchoring the leafletportion 610, while the leaflet portion 610 can be positionedsupraannularly (e.g., above the native valve annulus).

Lower portion 608 includes a stent structure 612 (e.g., a wire meshframe) that can comprise, for example, a plurality of open cells 615.Open cells 615 can be differently shaped from one another, with someopen cells 615 being enlarged and/or asymmetrical with respect to otheropen cells 615. While not shown for clarity, lower portion 608 can alsoinclude a flexible sleeve (e.g., a fabric sleeve) and/or a sealingcomponent covering at least a portion of the stent structure 612. Forexample, a PET fabric sleeve can cover at least a portion of the stentstructure 612 such that the PET fabric sleeve can reduce orsubstantially eliminate leakage around the replacement valve 600.

The leaflet portion 610 can include a two-part scalloped frame 613 thatcomprises reinforcement elements 614 a, 614 b, 614 c andleaflet-supporting members 616 a, 616 b, 616 c. Leaflets can be securedbetween respective reinforcement elements 614 a, 614 b, 614 c andleaflet-supporting members 616 a, 616 b, 616 c. For example, a leafletcan be secured in place in a gap 617 defined between reinforcementelement 614 a and leaflet-supporting member 616 a. A portion of each ofthe leaflets can be sandwiched between the reinforcement elements andleaflet-supporting members such that the leaflets can operate (e.g.,open and close) within windows 619 defined by the reinforcement elements614 a, 614 b, 614 c. Such configurations can allow for the leaflets tobe secured to the replacement valve 600 without being covered by a frameor stent structure (e.g., without open cells 615 extending into or overthe leaflet windows 619). Thus, the diameter of the crimped replacementvalve 600 can be kept to a minimum.

Commissure posts 620 are located between each of the leaflets, at thelocations where adjacent reinforcement arcs come together (e.g., wherereinforcement element 614 a and leaflet-supporting member 616 a meetreinforcement element 614 b and leaflet-supporting member 616 b).

FIGS. 4-5 illustrate another embodiment of a replacement heart valve 400that can be fully assembled prior to delivery, and transitioned from adelivery position or configuration (FIG. 4) to an operating position orconfiguration (FIG. 5) once the replacement valve has passed through thenarrowest part or parts of the patient's vasculature. Transition fromthe delivery position to the operating position can be performed, forexample while the replacement valve 400 is within the patient's aortaprior to implantation at the native valve. Alternatively, transitionfrom the delivery position to the operating position can be performedafter deployment of the replacement valve at the target site (e.g., thenative valve annulus).

Replacement valve 400 can include a frame structure, or stent, 402 andleaflets 404. A flexible sleeve 406 (e.g., a PET or Nitinol-PETcomposite fabric sleeve) can be coupled at one end 410 to the stent 402,such as by sutures 408 (e.g., the inner surface of the flexible sleeve406 can be coupled to the outer or external surface of the stent 402).The flexible sleeve 406 can also be coupled to the leaflets 404, and canthus allow for separation of the leaflets 404 from the upper end 412 ofthe stent 402 along the axial direction while the replacement valve isin the delivery configuration. The replacement valve can thus be fullyassembled in the delivery configuration, and yet allow for axialseparation of the leaflets 404 from the stent 402. Because the leaflets404 lie entirely outside of the frame structure during delivery of thevalve, the valve can be crimped to a very small profile.

The leaflets 404 can each include a first end 424 and a second end 426.The first end 424 can be scalloped and can be coupled to an upperportion 407 of the flexible sleeve 406. In some embodiments, theleaflets 404 can be mounted or coupled to an outer surface 409 of theflexible sleeve 406, such as by sutures 411. The second end 426 of theleaflets 404 can be positioned on the outer surface 409 of the flexiblesleeve 406 while in the delivery configuration, but the second end 426of the leaflets 404 is not secured to the flexible sleeve 406 in someembodiments to allow the leaflets to coapt when placed in the operatingconfiguration (e.g., the second end 426 of the leaflets 404 can be freeto move with respect to the flexible sleeve 406).

As shown in FIG. 5, after the replacement valve 400 has beentransitioned to its operating configuration, the second ends 426 of theleaflets 404 are free to open and close, and thus are not secured to theflexible sleeve 406 except at the commissures 428.

To transition the replacement valve 400 from the delivery configurationshown in FIG. 4 to the operating configuration shown in FIG. 5, theflexible sleeve 406 can be inverted or flipped outside in (or insideout) by pushing or pulling the upper portion 407 of the sleeve 406inwardly and downwardly (in FIG. 4) into the stent 402. Thus, a portion429 of the flexible sleeve 406 can be folded over the upper end 412 ofthe stent 402 in the operating configuration. As a result of such atransition, the outer surface 409 of the flexible sleeve 406 can bepositioned within and facing the interior lumen 430 of the replacementvalve 400. Thus, the flexible sleeve 406 can be inverted such that theupper portion 407 of the flexible sleeve 406 is moved to a positionwithin the lumen 430 of the stent 402 (e.g., at a position below thelower end 410 of the flexible sleeve 406).

In some embodiments, a conventional delivery system can be used totransition replacement valve 400 from a delivery configuration to anoperating configuration. For example, the flexible sleeve 406 (e.g., theupper portion 407 of the flexible sleeve 406) can be releasably coupledto the delivery system. After deployment (e.g., expansion and/or removalof a restraining sheath) of the stent 402 and/or optional temporaryframe 418, the delivery system can be advanced towards the patient'sleft ventricle, thereby pulling, dragging, or pushing the fabric sleeve406 into the lumen 430 of the replacement valve 400, and inverting thevalve leaflets 404.

During transition, the leaflets 404 can be inverted, such that thesecond end 426 of the leaflets 404 moves from being below the first end424 in the delivery configuration to being above the first end 424 inthe operating configuration. Further, as a result of transitioning, theleaflets 404, which can be outside of the lumen 430 in the deliveryconfiguration shown in FIG. 4, can be at least partially positionedwithin (e.g., inside) the lumen 430 of the replacement valve 400 in theoperating configuration shown in FIG. 5.

In the operating configuration, both the leaflets 404 and the flexiblesleeve 406 can be positioned at least partially inside the lumen 430 ofthe stent 402. In some embodiments, the flexible sleeve 406 can bestretched down into the lumen 430 of the stent 402, and anchored to thestent 402 (e.g., anchored near the lower end 417 of the stent 402 and/ornear the upper end 412 of the stent 402) while in the operatingconfiguration. For example, the flexible sleeve 406 can be secured inplace within the lumen 430 of the stent 402 by being coupled to thestent 402 by any suitable attachment structure. In one specificembodiment, an additional stent structure can be arranged to sandwichthe flexible sleeve 406 to the stent 402 after the replacement valve 400has been transitioned to its operating configuration. For example, anadditional stent structure can be expanded within the sleeve 406 (e.g.,within the lumen 430, near the lower end 417) to push at least a portionof the sleeve 406 against the stent 402, thereby anchoring the sleeve406 in place in an operating configuration.

Replacement valve 400 can optionally include a temporary valve, such astemporary valve 414 that can be coupled to the stent 412 by, forexample, one or more connecting posts 416 extending from the lower end417 of the stent 402 (e.g., opposite the upper end 412 of stent 402).When included, the temporary valve 414 can operate for a relativelyshort period of time (e.g., a matter of hours, or less) as a temporaryreplacement valve during the time between initial deployment ofreplacement valve 400 in its delivery configuration and the transitionto its operating configuration.

Optional temporary valve 414 can include temporary valve frame 418 andtemporary valve leaflets 420. Temporary valve frame 418 can, forexample, be an annular stent-like structure having a plurality ofangularly spaced, vertically extending commissure attachment posts orstruts 422. Commissure posts 422 can be positioned between adjacentleaflets 420. Commissure posts 422 can serve as points of attachmentbetween the temporary valve frame 418 and the temporary valve leaflets420. Commissure posts 422 can be interconnected via one or more rows ofcircumferentially extending struts 423. The struts 423 in each row canbe arranged in a zigzag or generally saw-tooth-like pattern extending inthe direction of the circumference of the frame 418 as shown. Temporaryvalve 414 can be any structure suitable for temporarily serving as areplacement heart valve, and need not have the structure illustrated inFIG. 4. In some embodiments, temporary valve 414 comprises a minimalamount of material.

In some embodiments, after replacement valve 400 is transitioned to itsoperating configuration, the leaflets 404 and/or flexible sleeve 406 canhold the temporary valve 414 in an open configuration. In suchconfigurations, the open temporary valve (e.g., the open temporary valveleaflets 420) can serve as a skirt or sealer for the replacement valve400. In some embodiments, the flexible sleeve 406 can be secured to thestent 402 by any suitable attachment structure. In one specificembodiment, an additional stent structure can be arranged to sandwichthe flexible sleeve 406 to the stent 402 and/or to the temporary valveframe 418 after the replacement valve 400 has been transitioned to itsoperating configuration.

In some embodiments, the temporary valve 414 can be removed from thereplacement valve 400, such as along with removal of the delivery systemused to implant the replacement valve 400. In other embodiments, thetemporary valve can remain in place, coupled to the replacement valve400. In some embodiments, the temporary valve 414 can be resorbable. Insome embodiments, the temporary valve can be integral to the replacementvalve 400 (e.g., the temporary valve can comprise slits cut through theflexible sleeve 406).

FIGS. 7-8 illustrate another embodiment of a replacement heart valve700. Replacement valve 700 can be at least partially delivered in adelivery configuration (FIGS. 7 and 8A) and then transitioned to anoperating configuration (FIG. 8B).

Replacement valve 700 generally comprises a frame, or stent 702 (e.g., acollapsible stent), a valve portion 704, and a flexible skirt, or sleeve706 (e.g., a PET fabric sleeve). In one particular embodiment, the stent702 can comprise interconnected wires or struts that zigzag to creatediamond-shaped cells 707 which can facilitate anchoring of thereplacement valve 700 within a patient's valve. While cells 707 can begenerally diamond-shaped, other shapes of open cells can also beincluded, such as the irregular open cells 807 shown in FIG. 8C. Theflexible sleeve 706 can couple the valve portion 704 to the frame 702.The flexible sleeve 706 can be coupled to the stent 702, such as bybeing sutured to the stent 702 along an upper portion 714 of the stent702.

The leaflets 708 of the valve portion 704 can be supported by a slimframe 710, such as the two-part scalloped frame 710 best seen in FIG. 7.Embodiments of the two-part scalloped frame 710 can be provided without,for example, diamond-shaped cells 707. In some embodiments, the two-partscalloped frame 710 does not include any cells other than the windowopenings for the leaflets 708 (e.g., the two-part scalloped frame 710can be lacking a portion suitable for anchoring the device in placewithin the patient's valve). Thus, the leaflets 708 can be attached to aportion of the replacement valve 700 having less material than, forexample, the stent 702 portion. In other embodiments, the two-partscalloped frame 710 can comprise a plurality of open cells, but in someembodiments, the open cells do not overlap with the leaflets. Forexample, FIG. 8C shows a valve portion 800 having a two-part scallopedframe 810 supporting leaflets 808. Open cells 807 can be provided, forexample, at the points 811 where adjacent arcs of the two-part scallopedframe 810 meet. As shown in FIG. 8C, however, in some embodiments, theopen cells 807 do not extend past the two-part scalloped frame 810, andthus do not overlap with the leaflets 808.

To transition from the delivery configuration (FIGS. 7 and 8A) to anoperating configuration (FIG. 8B), the valve portion 704 can be slidinto the lumen 703 of stent 702. For example, the replacement valve 700can be delivered to a patient's valve, such as by being delivered on acatheter through a patient's femoral artery, while the components (e.g.,the valve portion 704, the stent 702, and the flexible sleeve 706) arealigned in a stack (i.e., in a row or adjacent to one another in theaxial direction along the delivery catheter) to minimize the crimpedprofile of the replacement valve 700. In some embodiments, the valveportion 704, the stent 702, and the flexible sleeve 706 can form asingle integral structure that can be advanced through the patient'svasculature as a single unit. Transition of the replacement valve 700 toan operating configuration can take place at any point after thereplacement valve has been delivered past the narrowest points it willtravel through in the patient's vasculature (e.g., after travelingthrough the femoral artery). For example, the replacement valve 700 canbe transitioned to an operating configuration while in the abdominal orascending aorta. In some embodiments, the replacement valve 700 can betransitioned to an operating configuration before, during, or afterimplantation in the native valve.

FIG. 8A shows a cross section of the replacement valve 700 shown in FIG.7, shown in a delivery configuration. To transition to the operatingconfiguration shown in FIG. 8B, the valve portion 704 can be pulled orpushed inside the stent 702 (e.g., into the lumen 703 of the stent 702)while the flexible sleeve 706 is inverted and/or folded onto itself. Theouter surface 712 of the flexible sleeve in the delivery configuration(FIG. 8A) can thus become an interior surface 712 in the operatingconfiguration (FIG. 8B), facing the lumen 703 of stent 702. In someembodiments, the valve portion 704 can be at least partially crimpedwhile being inserted into the stent 702. In some embodiments, the valveportion 704 can be configured to self-expand after it is released intothe lumen 703 of the stent 702. For example, the valve portion 704 canbe at least partially restrained (e.g., crimped) by a sheath while it isbeing positioned inside the stent 702. Once the sheath is removed, thevalve portion 704 can self-expand inside the lumen 703 of the stent 702.

Thus, in the operating configuration, both the valve portion 704 and theflexible sleeve 706 can be positioned inside the lumen 703 of the stent702. In some embodiments, the flexible sleeve 706 can be stretched downinto the lumen of the stent 702, and anchored to the stent 702 while inthe operating configuration (e.g., anchored to the upper portion 714 ofthe stent 702). For example, the flexible sleeve 706 can be secured inplace within the lumen 703 of the stent 702 by being coupled to thestent 702 by any suitable attachment structure. In one specificembodiment, an additional stent structure can be arranged to sandwichthe flexible sleeve 706 to the stent 702 after the replacement valve 700has been transitioned to its operating configuration. For example, anadditional stent structure can be expanded within the sleeve 706 to pushthe sleeve 706 against the outer stent 702, thereby anchoring the sleeve706.

FIGS. 9-10 illustrate another embodiment of a replacement valve 900having a flexible sock, skirt, or sleeve 902 (e.g., a fabric sleeve)that can be inserted into the lumen 903 of a stent portion 904 before,during, or after delivery of the replacement valve 900 to a patient'snative valve. FIG. 9 shows the replacement valve 900 in a deliveryconfiguration and FIG. 10 shows the replacement valve 900 in anoperating configuration.

The flexible sleeve 902 can extend along substantially the entire lengthof the replacement valve 900 and can couple the stent portion 904 to avalve portion 910. For example, the flexible sleeve can extend from alower edge 906 of the stent portion 904 to an upper edge 908 of thevalve portion 910 that includes leaflets 912. A lower end 913 of theflexible sleeve 902 can be positioned adjacent an inner surface 914 ofthe stent portion 904 and coupled to the stent portion 904, such as bysutures 916. The flexible sleeve 902 can be positioned adjacent an outer(e.g., exterior) surface of an upper stent, or frame structure, of thevalve portion 910, such that the flexible sleeve 902 at leastsubstantially covers the upper frame structure. Suitable framestructures for the upper stent underlying the flexible sleeve 902include, for example, the upper stent 800 illustrated in FIG. 8C, aswell as the valve portions or leaflet structures from any otherdisclosed embodiment, or combinations thereof. The flexible sleeve 902can be coupled to the upper frame structure, such as by sutures 918. Theflexible sleeve 902 can be coupled to leaflets 912, such as by sutures920.

A middle portion 922 of the flexible sleeve 902 can be fabric (or otherflexible material) alone, without any underlying frame structures. Thiscan allow for a minimized crimped profile when the replacement valve 900is crimped onto a delivery device in the delivery configuration shown inFIG. 9. When transitioning to the operating configuration shown in FIG.10, the valve portion 910 can be pushed or pulled into the lumen 903 ofthe stent portion 904.

Once the transition is complete, substantially the entire valve portion910 and flexible sleeve 902 can be positioned within the lumen 903 ofthe stent portion 904. Thus, the flexible sleeve 902 can be compressedor folded onto itself, and can be substantially positioned between anouter surface up the upper frame and an inner surface of the stentportion 904 in the operating configuration.

FIGS. 11-21 illustrate specific methods of implanting embodiments of areplacement valve (e.g., the replacement valves shown in FIGS. 7-10),using simplified representations for clarity. In one method, shown inFIGS. 11-17, a replacement valve 1100, which is a simplifiedrepresentation of the valve shown in FIGS. 9-10, can be at leastpartially transitioned from a delivery configuration to an operatingconfiguration before placement within the native valve.

FIG. 11 shows a replacement valve 1100 in a delivery configuration on adelivery catheter 1102. Replacement valve 1100 can include a stent, orframe portion 1104 that is crimped onto a balloon 1106. In otherembodiments, the stent portion 1104 can be self-expandable. Replacementvalve 1100 can also include a valve portion 1108 that is crimped ontothe delivery catheter shaft 1102 at a location spaced away from thestent portion 1104, along the length of the delivery catheter 1102(e.g., the valve portion 1108 can be separated from the stent portion1104 along the axial direction of the delivery catheter 1102). The valveportion 1108 can be coupled to the stent portion 1104 by a flexiblesleeve 1110. The replacement valve 1100 can then be inserted into thebody (e.g., at the femoral artery) and navigated through a patient'svasculature to a suitable location, such as to the abdominal aorta, tobegin transitioning the valve to its operating configuration. Anylocation within the vasculature that can allow for the partial (e.g.,tapered) expansion of the stent portion as described below in connectionwith FIGS. 11-17 is suitable.

As shown in FIG. 12, once the replacement valve 1100 has been navigatedthrough the narrowest parts of the patient's vasculature, thereplacement valve can begin to be transitioned from the deliveryconfiguration to the operating configuration. In one embodiment, thestent portion 1104 can be partially expanded (e.g., by at leastpartially inflating a balloon 1106 that is positioned on the deliverycatheter under at least a portion of the stent portion 1104) while in,for example, the patient's abdominal or ascending aorta. The balloon1106 can be configured to partially expand the stent portion 1104 toform a tapered shape as shown, by, for example, positioning the stentportion such that one end 1116 is mounted off of the balloon 1106. Thestent portion 1104 can be partially expanded enough to allow for atleast partial insertion of the valve portion 1108 into the lumen of thestent portion 1104. The balloon 1106 can then be deflated, as shown inFIG. 13, to facilitate transitioning of the replacement valve 1100 fromthe delivery configuration to the operating configuration.

Once the balloon 1106 is deflated, the valve portion 1108 (which can beat least partially crimped) can be pushed into the lumen of the stentportion 1104, such as by pushing an outer shaft 1114 against the valveportion 1108 in the distal direction. FIG. 14 illustrates the mating ofthe stent portion 1104 to the valve portion 1108 (the rest of thedelivery catheter 1102 and outer shaft 1114 are not shown in FIG. 14,for clarity). In FIG. 14, the valve portion 1108 has been partiallyinserted into the lumen of the stent portion 1104. FIGS. 15-17 show thevalve portion 1108 fully inserted into the lumen of the stent portion1104.

The flexible sleeve 1110 can be configured to limit the motion of thevalve portion 1108 such that the flexible sleeve 1110 stops the valveportion 1108 from being pushed too far into the stent portion 1104. Theflexible sleeve 1110 can be sized and designed to provide for thedesired positioning of the valve portion 1108 within the stent portion1104. At this stage, the valve portion 1108 and the stent portion 1104are both positioned on the balloon 1106 (not visible in FIG. 14).

Once the replacement valve 1100 has been transitioned to its operatingconfiguration, the replacement valve 1100 can then be navigated furtherand positioned within the native valve annulus 1112, as shown in FIG.15. The steerable outer shaft 1114 can facilitate positioning of thereplacement valve 1100 within the native valve annulus, and can then bemoved (e.g., the outer shaft 1114 can be retracted slightly as shown inFIG. 16), so as not to interfere as the replacement valve 1100 isfurther expanded. Rapid pacing can be performed, as is known in the art.As shown in FIG. 16, the balloon 1106 can be inflated to fully expandthe replacement valve 1100 (e.g., the valve portion 1108 and the stentportion 1104 can be expanded together, at the same time). Balloon 1106can then be deflated, rapid pacing can be stopped, and the deliverycatheter 1102 can be removed from the patient. FIG. 17 shows thereplacement valve 1100 in an operating configuration (e.g., with thevalve portion 1108 positioned inside the lumen of the stent portion1104) within the patient's native valve annulus 1112.

In some embodiments, a replacement valve can be transitioned to anoperating configuration during implantation at the native valve site,rather than before positioning at the native valve site (e.g., thereplacement valve can be transitioned to its operating configurationonce at least part of the replacement valve has been positioned in thenative valve). For example, FIGS. 18 to 21 illustrate one such method.In this method, a replacement valve 1800 having a stent portion 1804 anda valve portion 1808 can be crimped onto a delivery catheter 1802. Asshown in FIG. 18, the replacement valve 1800 can be navigated to theimplantation site and positioned, such that the replacement valve 1800is at least partially positioned within the native valve annulus 1812 inits crimped state on the delivery catheter 1802. Thus, at least part ofthe stent portion 1804 is positioned to engage with the native valve(e.g., positioned such that at least part of the stent portion 1804contacts the valve annulus 1812, once the stent portion 1804 isexpanded).

As shown in FIG. 19, the stent portion 1804 can then be expanded to itsfunctional size (e.g., by a balloon, or the stent can beself-expanding), while at least a portion of the flexible sleeve 1810and the valve portion 1808 remain crimped on the delivery catheter 1802.The stent portion 1804 can be expanded to a diameter sufficient toengage the native valve annulus 1812, thereby anchoring the replacementvalve 1800.

In some embodiments, the flexible sleeve 1810 can be provided with oneor more slits or cutouts 1814 that can serve as temporary leaflets thatallow blood to flow through the replacement valve 1800 while it is beingimplanted. Rapid pacing can be performed, as is known in the art. Oncethe stent portion 1804 has been expanded and is engaged with the nativevalve annulus 1812, the balloon 1806 can be deflated. This allows roomwithin the lumen of the stent portion 1804 for the valve portion 1808and the flexible sleeve 1810 to be inserted, thus facilitatingtransitioning of the replacement valve 1800 from the deliveryconfiguration (FIGS. 18-19) to the operating configuration (FIGS.20-21).

FIG. 20 shows the replacement valve 1800 after the valve portion 1808has been pushed and expanded into (e.g., by balloon or self-expansion)the expanded stent portion 1804. A flex catheter 1816 can be used topush the valve portion 1808 and position it within the stent portion1804, on the balloon 1806. The flexible sleeve 1810 can be insertedinside the lumen of the stent portion 1804 as the valve portion 1808 isbeing inserted. The flexible sleeve 1810 can be designed to serve as astopper, to prevent the valve portion 1808 from being pushed too farinto the stent portion 1804. At least a portion of the flexible sleeve1810 is thus positioned between the inner surface of the stent portion1804 and the outer surface of the valve portion 1808.

The flex catheter 1816 can be at least partially retrieved and theballoon 1806 can be inflated, as shown in FIG. 21. Inflation of theballoon 1806 can expand the valve portion 1808 until it engages withand/or is coupled to the stent portion 1804, such as by friction. Oncethe replacement valve 1800 has thus been transitioned to an operatingconfiguration, the balloon 1806 can be deflated, rapid pacing can bestopped, and the delivery system (e.g., delivery catheter 1802) can beremoved from the patient.

FIG. 22 illustrates another embodiment of an upper stent or frame 2200that can be incorporated into any of the embodiments described. Frame2200 can include reinforcement elements 2202 that can serve to definewindows 2206 for leaflets. Leaflet-supporting members 2204 can bepositioned with respect to the reinforcement elements 2202 to secure theleaflets in place within the windows 2206. For example, a gap 2212 canbe created between a lower portion 2214 of the reinforcement elements2202 and the leaflet-supporting members 2204, and a portion of a leafletcan be inserted into each gap 2212. The reinforcement elements 2202 andleaflet-supporting members 2204 can be arranged to form an upper frame2200, such as the generally duckbill shaped upper frame 2200 shown inFIG. 22.

Frame 2200 can optionally include open cells 2208 between some or all ofthe adjacent leaflet-supporting members 2204. Additionally oralternatively, the frame 2200 can optionally include a lower rail 2210extending around the circumference of the lower portion of the frame2200. Adjacent reinforcement elements 2202 can be coupled by commissureposts 2212. Commissure posts 2212 can be designed, in some embodiments,to lack sharp, abrupt edges, thus providing a smooth surface. In someembodiments, the upper frame 2200 can be configured to contact thenative valve tissue when implanted, while in other configurations, theupper frame 2200 can be configured such that a gap exists between thereinforcement elements 2202 and the valve or vessel wall.

FIG. 23 illustrates one embodiment of a lower stent or frame 2300 thatcan be incorporated into any of the embodiments described. Frame 2300can, for example, comprise a wire mesh of cells 2302 arranged in, forexample, a substantially cylindrical tube. Frame 2300 can optionallyinclude a circumferential rail 2304 extending around a lower portion ofthe frame 2300.

Frame 2200 (FIG. 22) and frame 2300 (FIG. 23) can form the twocomponents of a two-part replacement valve. Frame 2200 can be positionedwithin the lumen 2306 of frame 2300, and rails 2210 and 2304 can bedesigned to interlock with one another to secure the two frames 2200,2300 together. In other embodiments, such as the embodiment describedmore fully below with reference to FIG. 26, a longitudinal railextending along the axis of frames 2200 and 2300 can connect the twoframes and allow for frame 2200 to slide into the lumen 2306 of frame2300. In alternative embodiments, frame 2200 and frame 2300 can becoupled to one another, such as by connecting posts that extend betweenframe 2200 and frame 2300. Either or both of frame 2200 and frame 2300can also be included in embodiments comprising flexible (e.g., fabric)sleeves, described above.

FIGS. 24-25 illustrate another embodiment of a replacement heart valve2400 that can be transitioned from a delivery configuration (FIG. 24) toan operating configuration (FIG. 25). Replacement valve 2400 cancomprise a stent 2402 and leaflets 2404. Each leaflet 2404 can besecured to a U-shaped support rod 2406. In the delivery configuration(FIG. 24), the leaflets 2404 and support rods 2406 are outside of thestent 2402, coupled to a first end 2408 of the stent 2402, such as byattachment points 2410. Attachment points 2410 can be individual hingepoints for each of the leaflets 2404. Hinges or equivalent mechanismscan be used to couple the ends of rods 2406 to the upper end of thestent 2402. In alternate embodiments, the attachment points 2410 cancomprise a single annular ring extending around the circumference of thestent 2402, adjacent the first end 2408 of the stent 2402. In someembodiments, the attachment points 2410 can comprise narrowedtransitional segments that can allow the attachment points 2410 toeasily deform or fold. Additionally or alternatively, the support rods2406 can be coupled to the stent 2402 by secondary attachment means,such as one or more sutures or wires.

To transition to the operating configuration (FIG. 25), the leaflets2404 and support rods 2406 can be flipped (e.g., inverted), rotated, orbent inwards (e.g., into the lumen 2412 of the stent 2402) so that theleaflets 2404 and support rods 2406 are positioned at least partiallywithin the lumen 2412 of the stent 2402. For example, in someembodiments, the attachment points 2410 can bend approximately 180degrees to allow inversion and/or eversion of the leaflets 2404 andsupport rods 2406. In some embodiments, the attachment points 2410 canbe configured to twist as the heart valve 2400 is being transitioned tothe operating configuration. In some embodiments, the heart valve 2400can be transitioned to the operating configuration without requiringdeformation of the attachment points 2410. For example, in someembodiments, hinges can allow for inversion and/or eversion of thesupport rods 2406 and leaflets 2404 without requiring deformation of anymetallic components. In some embodiments, the leaflets 2404 and supportrods 2406 can be flipped inside the stent 2402 after the stent 2402 isradially expanded (e.g., after the stent 2402 is radially expandedwithin the native valve annulus).

In some embodiments, the replacement valve 2400 can include a lockingmechanism (e.g., a snap fit locking mechanism) to prevent the leaflets2404 and support rods 2406 from repositioning back outside of the stent2402. For example, in one specific embodiment, one or more lower latchescan be positioned within the stent 2402 and configured to capture (e.g.,engage with) the support rods 2406 and/or the attachment points 2410 inorder to ensure proper positioning of the support rods 2406 and leaflets2404, and to prevent the heart valve from transitioning back to thedelivery configuration shown in FIG. 24. In some embodiments, thesupport rods 2406 and leaflets 2404 can be bi-stable, such that they arestable both when positioned outside of the stent 2402 in the deliveryconfiguration and stable when positioned inside of the stent 2402 in theoperating configuration.

FIG. 26 illustrates a two-part replacement heart valve 2600 thatcomprises a leaflet portion 2602 and a frame portion 2604 separated fromone another along the axial direction. The leaflet portion 2602 and theframe portion 2604 can thus be mounted separately from one another on adelivery catheter (see FIG. 27), thereby reducing the overall diameter(e.g., profile) of the crimped replacement valve because the twoportions need not be crimped on top of one another for delivery. Thetwo-part replacement valve 2600 can be pushed through a delivery sheathin a serial fashion, thus reducing the profile of the device. In someembodiments, the two parts (e.g., the leaflet portion 2602 and the frameportion 2604) of the two-part replacement valve can be coupled to oneanother during the entire delivery process. In other embodiments, thetwo parts can be separate from one another, and coupled together laterduring the delivery.

In one embodiment, the leaflet portion 2602 can be coupled to the frameportion 2604, for example, inside the descending aorta. In someembodiments, the leaflet portion 2602 can be pushed or pulled inside theframe portion 2604 by an expandable balloon that is part of the deliverysystem. The leaflet portion 2602 can be coupled to and/or docked withinthe frame portion 2604 by any suitable manner, such as, for example,rails, anchors, hooks, friction, interlocking components, and etc. Inone specific embodiment, one or more upper longitudinal rails 2606 thatare secured to the leaflet portion 2602 can be slid into and/or engagedwith respective one or more lower longitudinal rails 2608 that aresecured to the frame portion 2604 to couple the leaflet portion 2602 tothe frame portion 2604. Longitudinal rails 2606, 2608 can be configuredto engage with one another such that longitudinal rails 2606 can slideback and forth along longitudinal rails 2608 along the axial direction.

In some embodiments, the leaflet portion 2602 and the frame portion 2604are coupled to each other (e.g., coupled via upper and lower rails 2606,2608) during navigation through the patient's vasculature, and the twoparts can be moved relative to one another once in place in or near thenative valve annulus. For example, the two-part replacement valve 2600can be delivered to or near a target site while the leaflet portion 2602and the frame portion 2604 are coupled to one another by rails 2606,2608, yet separated from one another in the axial direction. The upperrails 2606 of the leaflet portion 2602 can be slid along the lower rails2608 of the frame portion 2604 to insert the leaflet portion 2602 withinthe lumen 2610 of the frame portion 2604.

In some embodiments of delivering replacement valve 2600, the deliverysystem (e.g., a FlexCath®), leaflet portion 2602, and frame portion 2604can individually be pushed through a sheath in a serial manner.

FIG. 27 illustrates the replacement valve 2600 shown in FIG. 26 crimpedonto a delivery system 2700. The replacement valve 2600 (e.g., the frameportion 2604 and the leaflet portion 2602) can be crimped onto thedelivery system 2700 at a location separated axially from a balloon2702. Thus, in some embodiments, no part of the replacement valve 2600is mounted or crimped onto the balloon 2702 during initial navigationthrough the patient's vasculature. This can help to keep the crimpedprofile of the replacement valve 2600 and delivery system 2700 to aminimum. Embodiments of suitable delivery systems are described furtherin U.S. Patent Application Nos. 61/170,065 and 61/179,311, which arehereby incorporated herein by reference, in their entirety.

The leaflet portion 2602 can be crimped onto delivery system 2700 at aposition separated axially from the frame portion 2604. The leafletportion 2602 can be coupled to the frame portion 2604, such as bylongitudinal rails 2606, 2608. The rails 2606, 2608 can help to keep theleaflet portion 2602 properly aligned with the frame portion 2604,and/or the rails 2606, 2608 can be configured to facilitate movement ofthe leaflet portion 2602 into the lumen of the frame portion 2604 at theappropriate time.

Delivery system 2700 can comprise a nose piece 2704 and an optional foampiece 2706 disposed on a guidewire shaft 2708 inside the balloon 2702.The balloon 2702 can include a split near a proximal end 2710 of theballoon 2702 (e.g., adjacent the replacement valve 2600) that can beconfigured to allow a tapered expansion of at least a portion of balloon2702 in order to facilitate positioning the replacement valve 2600 onthe balloon 2702. For example, after navigation to a suitable locationwithin a patient's vasculature, the balloon 2702 can be partiallyinflated and then retracted so that the leaflet portion 2602 is pushedor pulled at least partially into the lumen of the frame portion 2604 bythe at least partially inflated balloon 2702. As the leaflet portion2602 is being pushed into the frame portion 2604, the upper longitudinalrails 2606 move along the lower longitudinal rails 2608.

When the leaflet portion 2602 is positioned at least partially withinthe frame portion 2604, the balloon 2702 can be deflated. Then, both theleaflet portion 2602 and the frame portion 2604 can be positioned on theballoon 2702 at the target site, such as by pushing an outer catheter2712 against the proximal end of the frame portion 2604 to move theentire valve 2600 onto the balloon. The valve 2600 can be positionedover the foam core 2706, which can help retain the valve in place on theballoon while the valve is moved to the deployment site. Once the valveis positioned within the native valve annulus, the balloon 2702 can befully expanded so as to expand the leaflet portion 2602 and the frameportion 2604 together and anchor them into place within the native valveannulus.

While some disclosed embodiments have been illustrated as having ascalloped frame supporting the valve leaflets, other configurations arealso suitable. For example, stents having any shaped cells can beincluded in the disclosed embodiments.

Any of the disclosed embodiments can be provided with a self-expanding(e.g., comprising Nitinol) lower stent and/or leaflet support frame.Some embodiments include a balloon-expandable stent and/or valveportion. A self-expanding stent can be crimped or otherwise compressedinto a small tube and possesses sufficient elasticity to spring outwardby itself when a restraint such as an outer sheath is removed. Incontrast, a balloon-expanding stent is typically made of a material thatis substantially less elastic, and indeed must be plastically expandedfrom the inside out when converting from a compressed diameter to anexpanded diameter. It should be understood that the termballoon-expandable stents encompasses plastically-expandable stents,whether or not a balloon is used to actually expand it. The material ofthe stent plastically deforms after application of a deformation forcesuch as an inflating balloon or expanding mechanical fingers. Suitablematerials for the stent, frame, or reinforcement arc structures ofdisclosed embodiments include stainless steel, Nitinol, titanium,cobalt, chromium, nickel-based alloys (e.g., a nickel-cobalt-chromiumalloy such as MP35N™) polymers, and combinations and alloys thereof. Anyother materials that are rigid enough to impart the desired shape to thestructures are also suitable.

As described above, some embodiments of a replacement heart valveinclude a flexible sleeve or skirt. The flexible sleeve can comprise anymaterial that can allow transformation of the replacement valve from thedelivery configuration to the operating configuration. Suitablematerials include, for example, polyethylene terephthalate (PET) (e.g.,Dacron®), silicone, woven polyesters, polytetrafluoroethylene (PTFE),combinations thereof, or other similar materials. In some embodiments,the flexible sleeve can be sutured to the stent portion and/or to thevalve portion of the replacement valve. In other embodiments, the sleevecan be formed by dip coating the replacement valve in a liquefiedmaterial, such as liquefied silicone or other similar materials.

Leaflets can be formed of, for example, bovine pericardial tissue,biocompatible synthetic materials, or various other suitable natural orsynthetic materials as known in the art and described in U.S. Pat. No.6,730,118, which is incorporated by reference herein.

Any of the disclosed embodiments of a replacement heart valve can beconfigured to be positioned and anchored in place within a native valveand/or vessel by outward force of the replacement valve on the valveannulus and/or vessel wall, when in the operating configuration. Thus,in some embodiments, no other anchoring mechanism or structure ispresent. In alternative embodiments, a replacement valve can include oneor more anchoring mechanisms (e.g., hooks, anchors, barbs) to aid inanchoring the replacement valve.

Any of the disclosed embodiments of a replacement heart valve canoptionally include one or more radiopaque markers that can facilitatenavigation and tracking of the replacement valve through a patient'svasculature during delivery, transforming the valve from a deliveryconfiguration to an operating configuration, and/or positioning andimplanting the replacement valve at the target site (e.g., the nativevalve annulus). For example, one or more radiopaque markers can becoupled to the stent and/or leaflet support frame of a replacementvalve. In some embodiments, radiopaque material can be incorporated withthe material used to form the replacement valve.

Although the operations of exemplary embodiments of the disclosedmethods are described in a particular, sequential order for convenientpresentation, it should be understood that disclosed embodiments canencompass an order of operations other than the particular, sequentialorder disclosed. For example, operations described sequentially may insome cases be rearranged or performed concurrently. Additionally, thedescription sometimes uses terms such as “produce” and “provide” todescribe the disclosed method. These terms are high-level abstractionsof the actual operations that can be performed. The actual operationsthat correspond to these terms can vary depending on the particularimplementation and are, based on this disclosure, readily discernible byone of ordinary skill in the art.

In view of the many possible embodiments to which the principles of thedisclosed invention may be applied, it should be recognized that theillustrated embodiments are only preferred examples of the invention andshould not be taken as limiting the scope of the invention. Rather, thescope of the invention is defined by the following claims. We thereforeclaim as our invention all that comes within the scope and spirit ofthese claims.

We claim:
 1. A method of implanting a replacement heart valve,comprising: inserting into a patient's body a distal end portion of adelivery apparatus and a replacement heart valve mounted on the distalend portion of the delivery apparatus in a radially compressedconfiguration, the replacement heart valve comprising a metal stent, avalve portion, and a non-metal sleeve connecting the stent to the valveportion, wherein the stent comprises an outer surface and an innersurface defining a lumen, wherein the valve portion comprises a metalleaflet frame and a plurality of leaflets supported by the leafletframe, and wherein at least a portion of the leaflets are positionedoutside of the lumen defined by the stent during the act of inserting;positioning the stent within a native heart valve annulus; radiallyexpanding the stent such that the stent engages the native heart valveannulus; after radially expanding the stent, advancing the valve portionrelative to the expanded stent such that at least a portion of theleaflets are positioned within the lumen defined by the stent; and afteradvancing the valve portion relative to the expanded stent, radiallyexpanding the valve portion within the expanded stent.
 2. The method ofclaim 1, wherein the act of radially expanding the stent comprisesallowing the stent to self-expand within the native heart valve annulus.3. The method of claim 1, wherein the act of radially expanding thevalve portion comprises allowing the valve portion to self-expand withinthe expanded stent.
 4. The method of claim 1, wherein the act ofradially expanding the stent comprises inflating a balloon of thedelivery apparatus to cause the stent to expand.
 5. The method of claim1, wherein the act of radially expanding the valve portion comprisesinflating a balloon of the delivery apparatus to cause the valve portionto expand.
 6. The method of claim 1, wherein the sleeve comprises afabric.
 7. The method of claim 1, wherein the sleeve has a first endsutured to the stent and a second end sutured to the leaflet frame. 8.The method of claim 1, wherein the act of advancing the valve portionrelative to the expanded stent causes the sleeve to move to an invertedstate.
 9. A method of implanting a replacement heart valve, comprising:inserting into a patient's body a distal end portion of a deliveryapparatus and a replacement heart valve mounted on the distal endportion of the delivery apparatus in a radially compressedconfiguration, the replacement heart valve comprising a metal stent, avalve portion, and a sleeve connecting the stent to the valve portion,wherein the valve portion comprises a metal leaflet frame and aplurality of leaflets supported by the leaflet frame, and wherein thevalve portion is axially spaced from the stent during the act ofinserting; positioning the stent within a native heart valve annulus;radially expanding the stent such that the stent engages the nativeheart valve annulus while maintaining the valve portion in a radiallycompressed configuration; after radially expanding the stent, advancingthe valve portion relative to the expanded stent such that at least aportion of the leaflets are positioned within a lumen defined by thestent; and after the act of advancing the valve portion, radiallyexpanding the valve portion within the expanded stent.
 10. The method ofclaim 9, wherein the sleeve comprises a plurality of slits and bloodflows through the slits after the act of radially the stent and beforethe act of radially expanding the valve portion.
 11. The method of claim9, wherein the sleeve comprises a fabric sleeve sutured to the stent andthe leaflet frame.